A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001

Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2017

At a glance

  • Drugs DR 5001 (Primary)
  • Indications Adenovirus infections; Lung disorders
  • Focus Pharmacodynamics
  • Sponsors Duramed Pharmaceuticals Inc
  • Most Recent Events

    • 12 Apr 2017 Last checked against ClinicalTrials.gov record
    • 24 May 2012 Actual patient number 4041 added as reported by ClinicalTrials.gov.
    • 11 Dec 2008 BLA based on this trial accepted for review by the US FDA, reported by a Barr media release.
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